Foodstuffs - Detection of food allergens - General considerations and validation of methods

This document specifies how to use the standards for immunoassays, nucleic based and chromatographic methods and their relationship in the analysis of food allergens; and contains general definitions, requirements and guidelines for laboratory set-up, method validation requirements, description of methods, and test reports.
This document also specifies general guidelines for the requirements and use of reference materials for the determination of allergenic commodities in food products. The term "reference materials" in this document includes certified reference materials as well as quality control materials. Currently only a limited number of reference materials for food allergen determination are available. As new materials become accepted and validated, they can be appended as an annex to this document.
This document does not deal with sampling issues. It simply details processes involved from receipt of the laboratory sample to the end result.

Lebensmittel - Nachweis von Lebensmittelallergenen - Allgemeine Betrachtungen und Validierung von Verfahren

Dieses Dokument legt fest, wie die Normen zu Immunotests, auf Nukleinsäuren basierenden und chromatographischen Verfahren anzuwenden sind, und gibt deren Beziehung bei der Analyse von Lebensmittelallergenen an; es enthält allgemeine Definitionen, Anforderungen an und Leitlinien für den Aufbau von Laboratorien, Anforderungen an die Verfahrensvalidierung, Beschreibung der Verfahren und Untersuchungsberichte.
Dieses Dokument legt außerdem die allgemeinen Leitlinien für die Anforderungen und die Verwendung von Referenzmaterialien zur Bestimmung von allergenen Stoffen in Lebensmittelerzeugnissen fest. Der Begriff Referenzmaterial umfasst in diesem Dokument sowohl zertifizierte Referenzmaterialien als auch Qualitätskontrollmaterialien. Derzeit steht nur eine begrenzte Anzahl von Referenzmaterialien für die Bestimmung von Lebensmittelallergenen zur Verfügung. Wenn neue Materialien anerkannt und validiert worden sind, können sie als Anhang zu diesem Dokument hinzugefügt werden.
Das vorliegende Dokument beschäftigt sich nicht mit den Fragen der Probenahme. Es befasst sich lediglich im Einzelnen mit den vom Empfang der Laborprobe bis zum Endergebnis erforderlichen Prozessen.

Produits alimentaires - Détection des allergènes alimentaires - Considérations générales et validation des méthodes

Le présent document explique comment utiliser les étalons des méthodes basées sur les immunoessais, des méthodes chromatographiques et des méthodes basées sur l’acide nucléique, ainsi que leur relation dans l’analyse des allergènes alimentaires. Il contient également les définitions générales, les exigences et les lignes directrices relatives aux éléments suivants : l’installation du laboratoire, les exigences en matière de validation de la méthode, la description des méthodes et les rapports d’essai.
Le présent document spécifie également des lignes directrices générales relatives aux exigences et à l’utilisation des matériaux de référence pour doser les produits allergènes dans les produits alimentaires. Le terme « matériaux de référence » tel qu’il est utilisé ici englobe les matériaux de référence certifiés ainsi que les matériaux de contrôle de qualité. À ce jour il n’existe qu’un nombre limité de matériaux de référence pour doser les allergènes alimentaires. Dès que de nouveaux matériaux sont acceptés et validés, ils peuvent être ajoutés sous forme d’annexes au présent document.
Le présent document ne traite pas des questions d’échantillonnage. Il détaille simplement les processus en jeu, de la réception de l’échantillon pour laboratoire au résultat final.

Živila - Odkrivanje prisotnosti alergenov v živilih - Splošne ugotovitve in validacija metod

Ta dokument določa, kako uporabiti standarde za imunološke teste, nukleinske in kromatografske metode ter njihovo razmerje pri analizi prehranskih alergenov; vsebuje splošne opredelitve, zahteve in smernice za laboratorijsko pripravo, zahteve za validacijo metod, opis metod ter poročila o preskusih.
Ta dokument določa tudi splošne smernice za zahteve in uporabo referenčnih sestavin za določanje alergenih proizvodov v živilih. Izraz »referenčne sestavine« v tem dokumentu vključuje certificirane referenčne sestavine in sestavine za nadzor kakovosti. Trenutno je na voljo le omejeno število referenčnih sestavin za določanje alergenov v živilih. Ko bodo sprejete in potrjene nove sestavine, jih bo mogoče priložiti kot dodatek k temu dokumentu.
Ta dokument ne obravnava vprašanj vzorčenja. Opisuje zgolj postopke od prejema laboratorijskega vzorca do končnega rezultata.

General Information

Status
Published
Publication Date
01-Oct-2019
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
02-Oct-2019
Completion Date
02-Oct-2019

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SLOVENSKI STANDARD
SIST EN 15842:2019
01-december-2019
Nadomešča:
SIST EN 15842:2010

Živila - Odkrivanje prisotnosti alergenov v živilih - Splošne ugotovitve in validacija

metod

Foodstuffs - Detection of food allergens - General considerations and validation of

methods

Lebensmittel - Nachweis von Lebensmittelallergenen - Allgemeine Betrachtungen und

Verfahrensvalidierung

Produits alimentaires - Détection des allergènes alimentaires - Considérations générales

et validation des méthodes
Ta slovenski standard je istoveten z: EN 15842:2019
ICS:
67.050 Splošne preskusne in General methods of tests and
analizne metode za živilske analysis for food products
proizvode
SIST EN 15842:2019 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 15842:2019
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SIST EN 15842:2019
EN 15842
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2019
EUROPÄISCHE NORM
ICS 67.050 Supersedes EN 15842:2010
English Version
Foodstuffs - Detection of food allergens - General
considerations and validation of methods

Produits alimentaires - Détection des allergènes Lebensmittel - Nachweis von Lebensmittelallergenen -

alimentaires - Considérations générales et validation Allgemeine Betrachtungen und Verfahrensvalidierung

des méthodes
This European Standard was approved by CEN on 12 August 2019.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 15842:2019 E

worldwide for CEN national Members.
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SIST EN 15842:2019
EN 15842:2019 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

Introduction .................................................................................................................................................................... 4

1 Scope .................................................................................................................................................................... 5

2 Normative references .................................................................................................................................... 5

3 Terms and definitions ................................................................................................................................... 5

4 General aspects for methods and reference materials in food allergen analysis ................. 13

5 Guidance to the user for selection of methods .................................................................................. 14

6 Laboratory organization ........................................................................................................................... 15

7 Procedure........................................................................................................................................................ 15

8 Interpretation and expression of the results ..................................................................................... 16

9 Test report ...................................................................................................................................................... 17

Bibliography ................................................................................................................................................................. 18

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SIST EN 15842:2019
EN 15842:2019 (E)
European foreword

This document (EN 15842:2019) has been prepared by Technical Committee CEN/TC 275 “Food

Analysis - Horizontal Methods”, the secretariat of which is held by DIN.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by April 2020, and conflicting national standards shall be

withdrawn at the latest by April 2020.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN 15842:2010.

Significant technical changes between this standard and EN 15842:2010 are as follows:

a) documents under normative references removed (2);
b) updated terms and definitions (3);
c) general considerations for methods and reference materials added (4.1);

d) requirements regarding the production and storage of reference materials deleted (4.3);

e) clause on "Quality assurance requirements" deleted;
f) the test report should comply with EN ISO/IEC 17025;
g) updated bibliography.

According to the CEN-CENELEC Internal Regulations, the national standards organisations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,

Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of

North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the

United Kingdom.
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SIST EN 15842:2019
EN 15842:2019 (E)
Introduction

The main focus of this document is on immunoassays, chromatographic and nucleic acid based methods

for the determination of food allergens. However, because of the rapid developments in this area, other

technologies can be considered.

The analysis of food allergens is performed by means of the following successive (or simultaneous)

steps. After sample collection, proteins, nucleic acids or other markers are extracted from the test

portion. Extracted analytes can be further purified, simultaneously or after the extraction process.

Afterwards, they are diluted (if necessary) and subjected to analytical procedures such as

immunoassays (e.g. ELISA), nucleic acid based assays (e.g. PCR) or chromatographic (e.g. LC-MS).

These steps are detailed in this document and in the following documents:

EN 15633-1, Foodstuffs — Detection of food allergens by immunological methods — Part 1: General

considerations

EN 15634-1, Foodstuffs — Detection of food allergens by molecular biological methods — Part 1: General

considerations
For the use of this document the term:
— ‘shall’ indicates a requirement;
— ‘should’ indicates a recommendation;
— ‘may’ indicates a permission; and
— ‘can’ indicates a possibility and/or a capability.
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SIST EN 15842:2019
EN 15842:2019 (E)
1 Scope

This document specifies how to use the standards for immunoassays, nucleic based and

chromatographic methods and their relationship in the analysis of food allergens; and contains general

definitions, requirements and guidelines for laboratory set-up, method validation requirements,

description of methods, and test reports.

This document also specifies general guidelines for the requirements and use of reference materials for

the determination of allergenic commodities in food products. The term “reference materials” in this

document includes certified reference materials as well as quality control materials. Currently only a

limited number of reference materials for food allergen determination are available. As new materials

become accepted and validated, they can be appended as an annex to this document.

This document does not deal with sampling issues. It simply details processes involved from receipt of

the laboratory sample to the end result.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at https://www.iso.org/obp
3.1 Method performance characteristics
3.1.1
fitness for purpose

degree to which data produced by a measurement process enables a user to make technically and

administratively correct decisions for a stated purpose

Note 1 to entry: The measurement process can be based on a screening method, a confirmatory method or a

reference method.
Note 2 to entry: For further information refer to [10].
3.1.2
screening method

method that will rapidly and reliably eliminate (screen) a large number of negative (or positive) test

samples and restrict the number of test samples requiring the application of a rigorous method

Note 1 to entry: See [11].
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3.1.3
practicability

ease of operations, in terms of sample throughput and costs, to achieve the required performance

criteria and thereby meet the specified purpose
[SOURCE: EN ISO 24276:2006+A1:2013, 3.1.22]
3.1.4
selectivity

extent to which a method can determine particular analyte(s) in mixtures or matrices without

interferences from other components
Note 1 to entry: See [12].
3.1.5
sensitivity

change in the response divided by the corresponding change in the concentration of a standard

(calibration) curve
Note 1 to entry: See [12].
3.1.6
specificity

property of a method to respond exclusively to the characteristic or analyte under investigation

Note 1 to entry: See [12].
3.1.7
linearity

ability to elicit test results that are directly, or by means of well defined, mathematical transformations,

proportional to the concentration of analyte in samples within a given range
Note 1 to entry: For further information refer to [12].
3.1.8
applicability range

interval of quantity values within which the analytical procedure has been demonstrated by

collaborative trial or other appropriate validation to have a suitable level of precision and accuracy

3.1.9
limit of detection
LOD

minimum amount or concentration of the analyte in test sample which can be detected reliably but not

necessarily quantified, as demonstrated by a collaborative trial or other appropriate validation

3.1.10
limit of quantitation
limit of determination
LOQ

lowest concentration or amount of the analyte in a test sample which can be quantitatively determined

with an acceptable level of precision and accuracy, as demonstrated by collaborative trial or other

appropriate validation
Note 1 to entry: For further information refer to [13].
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EN 15842:2019 (E)
3.1.11
precision

closeness of agreement between independent test/measurement results obtained under stipulated

conditions

Note 1 to entry: Precision depends only on the distribution of random errors and does not relate to the true

value or the specified value.

Note 2 to entry: The measure of precision is usually expressed in terms of imprecision and computed as

standard deviation of the test results or measurements results. Less precision is reflected by a larger standard

deviation.

Note 3 to entry: Quantitative measures of precision depend critically on the stipulated conditions. Repeatability

conditions and reproducibility conditions are particular sets of extreme stipulated conditions.

[SOURCE: ISO 3534-2:2006, 3.3.4]
3.1.12 Repeatability related terms
3.1.12.1
repeatability
precision under repeatability conditions

Note 1 to entry: Repeatability can be expressed quantitatively in terms of the dispersion characteristics of the

results.
[SOURCE: ISO 3534-2:2006, 3.3.5]
3.1.12.2
repeatability conditions

observation conditions where independent test/measurement results are obtained with the same

method on identical test/measurement items in the same test or measuring facility by the same

operator using the same equipment within short intervals of time
Note 1 to entry: Repeatability conditions include:
— the same measurement procedure or test procedure;
— the same operator;
— the same measuring or test equipment used under the same conditions;
— the same location;
— repetition over a short period of time.
[SOURCE: ISO 3534-2:2006, 3.3.6]
3.1.12.3
repeatability limit
repeatability critical difference for a specified probability of 95 %
[SOURCE: ISO 3534-2:2006, 3.3.9]
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EN 15842:2019 (E)
3.1.12.4
repeatability standard deviation

standard deviation of test results or measurement results obtained under repeatability conditions

Note 1 to entry: It is a measure of the dispersion of the distribution of test or measurement results under

repeatability conditions.

Note 2 to entry: Similarly “repeatability variance” and “repeatability coefficient of variation” can be defined and

used as measures of the dispersion of test or measurement results under repeatability conditions.

[SOURCE: ISO 3534-2:2006, 3.3.7]
3.1.13
collaborative study

interlaboratory study in which each laboratory uses a defined method of analysis to analyse identical

portions of homogenous material to assess the performance characteristics obtained for the method of

analysis

Note 1 to entry: Guidelines for performing collaborative trials are elaborated in ISO 5725-1 [3] and in IUPAC

harmonized protocol 1995 [14].
3.1.14 Reproducibility related terms
3.1.14.1
reproducibility
precision under reproducibility conditions

Note 1 to entry: Reproducibility can be expressed quantitatively in terms of the dispersion characteristics of the

results.
Note 2 to entry: Results are usually understood to be corrected results.
[SOURCE: ISO 3534-2:2006, 3.3.10]
3.1.14.2
reproducibility conditions

observation conditions where independent test/measurement results are obtained with the same

method on identical test/measurement items in different test or measurement facilities by different

operators using different equipment
[SOURCE: ISO 3534-2:2006, 3.3.11]
3.1.14.3
reproducibility limit
reproducibility critical difference for a specified probability of 95 %
[SOURCE: ISO 3534-2:2006, 3.3.14]
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EN 15842:2019 (E)
3.1.14.4
reproducibility standard deviation

standard deviation of test results or measurement results obtained under reproducibility conditions

Note 1 to entry: It is a measure of the dispersion of the distribution of test or measurement results under

reproducibility conditions.

Note 2 to entry: Similarly, “reproducibility variance” and “reproducibility coefficient of variation” can be

defined and used as measures of the dispersion of test or measurement results under reproducibility conditions.

[SOURCE: ISO 3534-2:2006, 3.3.12]
3.1.15
recovery

proportion of the amount of analyte, present in or added to the analytical portion of the test material,

which is extracted and determined for measurement
Note 1 to entry: See [15].
3.1.16
metrological traceability

property of a measurement result whereby the result can be related to a reference through a

documented unbroken chain of calibrations, each contributing to the measurement uncertainty

[SOURCE: JCGM 200:2012, 2.41, modified — notes were removed]
3.1.17
trueness

closeness of agreement between the expectation of a test result or a measurement result and a true

value

Note 1 to entry: The measurement of trueness is usually expressed in terms of bias.

Note 2 to entry: Trueness is sometimes referred to as “accuracy of the mean”. This usage is not recommended.

Note 3 to entry: In practice, the accepted reference value is substituted for the true value.

[SOURCE: ISO 3534-2:2006, 3.3.3]
3.1.18
accuracy

closeness of agreement between a test result or measurement result and the true value

Note 1 to entry: In practice, the accepted reference value is substituted for the true value.

Note 2 to entry: The term “accuracy”, when applied to a set of test or measurement results, involves a

combination of random components and a common systematic error or a bias component.

Note 3 to entry: Accuracy refers to a combination of trueness and precision.
[SOURCE: ISO 3534-2:2006, 3.3.1]
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3.1.19
bias

difference between the expectation of a test result or measurement result and a true value

Note 1 to entry: Bias is the total systematic error as contrasted to random error. There could be one or more

systematic error components contributing to the bias. A larger systematic difference from the true value is

reflected by a larger bias value.

Note 2 to entry: The bias of a measuring instrument is normally estimated by averaging the error of indication

over an appropriate number of repeated measurements. The error of indication is the: “indication of a measuring

instrument minus a true value of the corresponding input quantity”.
[SOURCE: ISO 3534-2:2006, 3.3.2, modified — note 3 was removed]
3.1.20
robustness
ruggedness

measure of the capacity of an analytical procedure to remain unaffected by small variations in method

parameters and provides an indication of the method’s reliability during normal usage

[SOURCE: ISO 16577:2016, 3.184]
3.2 Sample and material related terms
3.2.1
matrix
components of the sample other than the analyte of interest

Note 1 to entry: Each matrix has generally a common name that permits classification.

3.2.2
laboratory sample

sample as prepared for sending to the laboratory and intended for inspection or testing

[SOURCE: ISO 78-2:1999, 3.1]
3.2.3
test sample

sample prepared from the laboratory sample and from which test portions will be taken

[SOURCE: ISO 78-2:1999, 3.2]
3.2.4
test portion

the quantity of material drawn from the test sample (or from the laboratory sample if both are the

same) and on which the test or observation is actually carried out
[SOURCE: ISO 78-2:1999, 3.3]
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